# FDA 483 - Triangle Machine, Inc. - April 27, 2022

Source: https://www.keypedia.com/records/483/triangle-machine-inc/caabda0a-53f2-47e2-af37-29f815f2f790

> FDA 483 for Triangle Machine, Inc. on April 27, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Triangle Machine, Inc.
- Inspection Date: 2022-04-27
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Triangle Machine, Inc. in South Bend, IN, a device manufacturer, was cited for multiple significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately maintain device history records, control nonconforming products, establish complaint handling procedures, conduct quality audits, and perform management reviews. These issues indicate a systemic lack of adherence to established quality system requirements.

## Related Officers

- [ Investigator ](https://www.keypedia.com/people/suyang-qin/c32419c5-1b78-4014-9f94-cb7ab17dfe05)

Company: https://www.keypedia.com/companies/triangle-machine-inc/21b285b2-6080-45a7-bfd1-200b96e2c741

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0